A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 19, 2019

Primary Completion Date

March 29, 2021

Study Completion Date

March 29, 2021

Conditions
Advanced Malignancies
Interventions
BIOLOGICAL

IBI188

"The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose.~The starting dose for part 1 is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 28 days.~Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days."

Trial Locations (4)

19107

Thomas Jefferson Univerity, Philadelphia

49546

START Midwest, Grand Rapids

77030

MD Anderson Cancer Center, Houston

78229

START (South Texas Accelerated Research Therapeutics, LLC), San Antonio

All Listed Sponsors
lead

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

NCT03763149 - A Study Evaluating the Safety, Tolerability, and Initial Efficacy of Recombinant Human Anti-cluster Differentiation Antigen 47 (CD47) Monoclonal Antibody Injection (IBI188) in Patients With Advanced Malignant Tumors and Lymphomas | Biotech Hunter | Biotech Hunter